Severe Prospective Observational COPD Catalonia

NCT06252805 | Not Yet Recruiting DMC

• 1 other identifier: FUC-SPOCCAT-2023-10
• Study Type: observational
• Target: 450
• Locations: 0 countries
• Sites: N/A

Brief Summary

Multicenter observational study to characterize and follow-up a cohort of patients with severe chronic obstructive pulmonary disease (COPD) in Catalonia

Conditions

Severe Chronic Obstructive Pulmonary Disease

Keywords

Severe COPD; Cohort; Catalonia; Prospective; Multicenter; 5 year follow-up; characterisation; COPD comorbidities; COPD phenotypes

Outcome Measures

Primary Outcomes (3)

• Cohort creation in Catalonia

  Creation of a long follow-up (5 years) cohort of severe COPD patients in Catalonia

  Up to 5 years

• Describe the demographic and clinical characteristics of patients with severe COPD in Catalonia.

  Identify the distribution of sex, age, severity of lung function impairment, treatment administered and comorbidities of severe COPD patients

  Up to 5 years

• Assess the natural history and prognosis of severe COPD

  Assess the decline in lung function, frequency and severity of exacerbations and survival over a period of 5 years

  Up to 5 years

Secondary Outcomes (3)

• Assess effect of the different treatments, both inhaled and non-inhaled, on the disease progression and according to the patient's phenotype.

  Up to 5 years

• Impact of exacerbations and chronic bronchial infection on the evolution of COPD

  Up to 5 years

• Importance of comorbidities in the evolution of COPD

  Up to 5 years

Study Arms (1)

SPOCCAT

Severe Chronic Obstructive Pulmonary Disease patients in Catalonia

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD subjects from respiratory departments in Hospitals from Catalonia

You may qualify if:

• Informed consent: a signed and dated written informed consent prior to study participation
• Age: Subjects 35 years of age or order at visit 1.
• Severe COPD diagnosis: an established severe COPD defined by spirometry values:
• A post-albuterol/salbutamol FEV1/FVC ratio of \<0.70 at visit 1. FEV1: forced expiratory volume at one second FVC: forced vital capacity.
• A post-bronchodilator FEV1 \< 50% predicted normal
• Smoking history: ≥ 10 pack-years at visit 1
• Stable phase of the disease (not less than 4 weeks of stability prior visit 1)

You may not qualify if:

• Subjects not giving written informed consent.
• Subjects at risk of non-compliance, or unable to comply with the scheduled visits.
• Subjects affected mainly by another severe chronic respiratory disease that justifies the ventilatory alteration, for example pulmonary fibrosis or severe bronchiectasis
• Subjects with carcinoma that has not been in complete remission for at least 5 years.
• Subjects with α1-antitrypsin deficiency as the underlying cause of COPD

Sponsors & Collaborators

• Ferran Morell: lead

Related Publications (15)

• Celli BR, Cote CG, Marin JM, Casanova C, Montes de Oca M, Mendez RA, Pinto Plata V, Cabral HJ. The body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary disease. N Engl J Med. 2004 Mar 4;350(10):1005-12. doi: 10.1056/NEJMoa021322.

  PMID: 14999112 BACKGROUND

• Almagro P, Soriano JB, Cabrera FJ, Boixeda R, Alonso-Ortiz MB, Barreiro B, Diez-Manglano J, Murio C, Heredia JL; Working Group on COPD, SpanishSociety of Internal Medicine*. Short- and medium-term prognosis in patients hospitalized for COPD exacerbation: the CODEX index. Chest. 2014 May;145(5):972-980. doi: 10.1378/chest.13-1328.

  PMID: 24077342 BACKGROUND

• Fletcher C, Peto R. The natural history of chronic airflow obstruction. Br Med J. 1977 Jun 25;1(6077):1645-8. doi: 10.1136/bmj.1.6077.1645.

  PMID: 871704 BACKGROUND

• Lokke A, Lange P, Scharling H, Fabricius P, Vestbo J. Developing COPD: a 25 year follow up study of the general population. Thorax. 2006 Nov;61(11):935-9. doi: 10.1136/thx.2006.062802.

  PMID: 17071833 BACKGROUND

• Kohansal R, Martinez-Camblor P, Agusti A, Buist AS, Mannino DM, Soriano JB. The natural history of chronic airflow obstruction revisited: an analysis of the Framingham offspring cohort. Am J Respir Crit Care Med. 2009 Jul 1;180(1):3-10. doi: 10.1164/rccm.200901-0047OC. Epub 2009 Apr 2.

  PMID: 19342411 BACKGROUND

• Vestbo J, Anderson W, Coxson HO, Crim C, Dawber F, Edwards L, Hagan G, Knobil K, Lomas DA, MacNee W, Silverman EK, Tal-Singer R; ECLIPSE investigators. Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points (ECLIPSE). Eur Respir J. 2008 Apr;31(4):869-73. doi: 10.1183/09031936.00111707. Epub 2008 Jan 23.

  PMID: 18216052 BACKGROUND

• Garcia-Aymerich J, Gomez FP, Anto JM; en nombre del Grupo Investigador del Estudio PAC-COPD. [Phenotypic characterization and course of chronic obstructive pulmonary disease in the PAC-COPD Study: design and methods]. Arch Bronconeumol. 2009 Jan;45(1):4-11. doi: 10.1016/j.arbres.2008.03.001. Epub 2009 Jan 3. Spanish.

  PMID: 19186292 BACKGROUND

• Regan EA, Hokanson JE, Murphy JR, Make B, Lynch DA, Beaty TH, Curran-Everett D, Silverman EK, Crapo JD. Genetic epidemiology of COPD (COPDGene) study design. COPD. 2010 Feb;7(1):32-43. doi: 10.3109/15412550903499522.

  PMID: 20214461 BACKGROUND

• Makita H, Nasuhara Y, Nagai K, Ito Y, Hasegawa M, Betsuyaku T, Onodera Y, Hizawa N, Nishimura M; Hokkaido COPD Cohort Study Group. Characterisation of phenotypes based on severity of emphysema in chronic obstructive pulmonary disease. Thorax. 2007 Nov;62(11):932-7. doi: 10.1136/thx.2006.072777. Epub 2007 Jun 15.

  PMID: 17573447 BACKGROUND

• Kunzli N, Ackermann-Liebrich U, Keller R, Perruchoud AP, Schindler C. Variability of FVC and FEV1 due to technician, team, device and subject in an eight centre study: three quality control studies in SAPALDIA. Swiss Study on Air Pollution and Lung Disease in Adults. Eur Respir J. 1995 Mar;8(3):371-6. doi: 10.1183/09031936.95.08030371.

  PMID: 7789479 BACKGROUND

• Downs SH, Brandli O, Zellweger JP, Schindler C, Kunzli N, Gerbase MW, Burdet L, Bettschart R, Zemp E, Frey M, Keller R, Tschopp JM, Leuenberger P, Ackermann-Liebrich U; SAPALDIA team. Accelerated decline in lung function in smoking women with airway obstruction: SAPALDIA 2 cohort study. Respir Res. 2005 May 26;6(1):45. doi: 10.1186/1465-9921-6-45.

  PMID: 15918902 BACKGROUND

• Lopez-Campos JL, Peces-Barba G, Soler-Cataluna JJ, Soriano JB, de Lucas Ramos P, de-Torres JP, Marin JM, Casanova C; en nombre del grupo de estudio CHAIN. Chronic obstructive pulmonary disease history assessment in Spain: a multidimensional chronic obstructive pulmonary disease evaluation. Study methods and organization. Arch Bronconeumol. 2012 Dec;48(12):453-9. doi: 10.1016/j.arbres.2012.05.006. Epub 2012 Jul 4. English, Spanish.

  PMID: 22766419 BACKGROUND

• Calle Rubio M, Rodriguez Hermosa JL, de Torres JP, Marin JM, Martinez-Gonzalez C, Fuster A, Cosio BG, Peces-Barba G, Solanes I, Feu-Collado N, Lopez-Campos JL, Casanova C; CHAIN Study Investigators. COPD Clinical Control: predictors and long-term follow-up of the CHAIN cohort. Respir Res. 2021 Feb 4;22(1):36. doi: 10.1186/s12931-021-01633-y.

  PMID: 33541356 BACKGROUND

• Chen CZ, Shih CY, Hsiue TR, Tsai SH, Liao XM, Yu CH, Yang SC, Wang JD. Life expectancy (LE) and loss-of-LE for patients with chronic obstructive pulmonary disease. Respir Med. 2020 Oct;172:106132. doi: 10.1016/j.rmed.2020.106132. Epub 2020 Aug 29.

  PMID: 32905891 BACKGROUND

• Soriano JB, Alfageme I, Miravitlles M, de Lucas P, Soler-Cataluna JJ, Garcia-Rio F, Casanova C, Rodriguez Gonzalez-Moro JM, Cosio BG, Sanchez G, Ancochea J. Prevalence and Determinants of COPD in Spain: EPISCAN II. Arch Bronconeumol (Engl Ed). 2021 Jan;57(1):61-69. doi: 10.1016/j.arbres.2020.07.024. Epub 2020 Sep 17. English, Spanish.

  PMID: 32950310 RESULT

Related Links

• GOLD COPD 2023 report (GOLD: Global Initiative for Chronical Obstructive Lung Disease)
• WHO (World Health Organization). The Top 10 causes ofr death

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: president

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: February 12, 2024
• Study Start: March 10, 2024
• Primary Completion: March 31, 2025
• Study Completion (Estimated): March 31, 2030
• Last Updated: February 12, 2024

Record last verified: 2024-02